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A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CP-690,550

Placebo

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Arthritis, Rheumatoid, Antirheumatic Agents, Clinical Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
Patient must remain on at least one background traditional disease modifying antirheumatic drug.
No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

Exclusion Criteria:

Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
History of any other rheumatic autoimmune disease other than Sjogren's syndrome.
No malignancy or history of malignancy.
History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Active 5 mg

Active 10 mg

Placebo Sequence 1

Placebo Sequence 2

Arm Description

Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.

Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6

ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6

ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.

Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12

Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Patient Assessment of Arthritis Pain at Month 9 and 12

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.

Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.

Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Physician Global Assessment (PGA) of Arthritis at Month 9 and 12

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.

36-Item Short-Form Health Survey (SF-36) at Month 9 and 12

Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.

Medical Outcome Study (MOS) Sleep Scale at Month 12

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6

FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12

Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).

Work Limitations Questionnaire (WLQ) Score at Month 12

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6

Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.

Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12

Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12

Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

Number of Days as Assessed Using RA-HCRU at Month 12

Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.

Number of Hours Per Day as Assessed RA-HCRU at Month 12

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12

Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.

Full Information

NCT ID

NCT00856544

First Posted

March 3, 2009

Last Updated

December 6, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00856544

Brief Title

A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Official Title

Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid, Antirheumatic Agents, Clinical Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

795 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active 5 mg

Arm Type

Experimental

Arm Title

Active 10 mg

Arm Type

Experimental

Arm Title

Placebo Sequence 1

Arm Type

Placebo Comparator

Arm Description

Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.

Arm Title

Placebo Sequence 2

Arm Type

Placebo Comparator

Arm Description

Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

Film coated tablet, 5 mg PO BID, 1 year

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

Film coated tablet, 10 mg PO BID, 1 year

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Film coated tablet, 1 tablet PO BID, 3-6 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Film coated tablet, 1 tablet PO BID, 3-6 months

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3

Description

Time Frame

Baseline, Month 3

Title

Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6

Description

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6

Description

Time Frame

Week 2, Month 1, 2, 3, 4.5, 6

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6

Description

Time Frame

Week 2, Month 1, 2, 3, 4.5, 6

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6

Description

Time Frame

Week 2, Month 1, 2, 3, 4.5, 6

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

Description

Time Frame

Week 2, Month 1, 2, 3, 4.5, 6

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12

Description

Time Frame

Month 12

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

Description

Time Frame

Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

Description

Time Frame

Baseline, Month 3, 6, 12

Title

Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

Description

Time Frame

Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Title

Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12

Description

Time Frame

Month 9, Month 12

Title

Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

Description

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Title

Patient Assessment of Arthritis Pain at Month 9 and 12

Description

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

Month 9, 12

Title

Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

Description

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.

Time Frame

Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Title

Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12

Description

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.

Time Frame

Month 9, 12

Title

Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6

Description

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Time Frame

Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Title

Physician Global Assessment (PGA) of Arthritis at Month 9 and 12

Description

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Time Frame

Month 9, 12

Title

36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

36-Item Short-Form Health Survey (SF-36) at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Medical Outcome Study (MOS) Sleep Scale at Month 12

Description

Time Frame

Month 12

Title

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12

Description

Time Frame

Month 12

Title

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12

Description

Time Frame

Month 12

Title

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12

Description

Time Frame

Month 12

Title

Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Work Limitations Questionnaire (WLQ) Score at Month 12

Description

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).

Time Frame

Month 12

Title

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12

Description

Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.

Time Frame

Month 12

Title

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12

Description

Time Frame

Month 12

Title

Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Number of Days as Assessed Using RA-HCRU at Month 12

Description

Time Frame

Month 12

Title

Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Number of Hours Per Day as Assessed RA-HCRU at Month 12

Description

Time Frame

Month 12

Title

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.

Time Frame

Baseline, Month 3, 6

Title

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12

Description

Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.

Time Frame

Month 12

Other Pre-specified Outcome Measures:

Title

Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis

Description

Patient global assessment of arthritis: participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.

Time Frame

2 weeks

Title

Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain

Description

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria. The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL. Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity. Patient must remain on at least one background traditional disease modifying antirheumatic drug. No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis. Exclusion Criteria: Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L. History of any other rheumatic autoimmune disease other than Sjogren's syndrome. No malignancy or history of malignancy. History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Pfizer Investigational Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Pfizer Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Pfizer Investigational Site

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Pfizer Investigational Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Pfizer Investigational Site

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Pfizer Investigational Site

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

Pfizer Investigational Site

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Pfizer Investigational Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Pfizer Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

Facility Name

Pfizer Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Pfizer Investigational Site

City

Port Richey

State/Province

Florida

ZIP/Postal Code

34668

Country

United States

Facility Name

Pfizer Investigational Site

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Pfizer Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Pfizer Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Pfizer Investigational Site

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Pfizer Investigational Site

City

Oakbrook Terrace

State/Province

Illinois

ZIP/Postal Code

60181

Country

United States

Facility Name

Pfizer Investigational Site

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61103-3692

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

Pfizer Investigational Site

City

Vernon Hills

State/Province

Illinois

ZIP/Postal Code

60061

Country

United States

Facility Name

Pfizer Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

Pfizer Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Pfizer Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40505

Country

United States

Facility Name

Pfizer Investigational Site

City

Leominster

State/Province

Massachusetts

ZIP/Postal Code

01453

Country

United States

Facility Name

Pfizer Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Pfizer Investigational Site

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Pfizer Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Pfizer Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Pfizer Investigational Site

City

Orchard Park

State/Province

New York

ZIP/Postal Code

14127

Country

United States

Facility Name

Pfizer Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Pfizer Investigational Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Pfizer Investigational Site

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Pfizer Investigational Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Pfizer Investigational Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Pfizer Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

Pfizer Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

Pfizer Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405-2308

Country

United States

Facility Name

Pfizer Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Pfizer Investigational Site

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

Pfizer Investigational Site

City

Campsie

State/Province

New South Wales

ZIP/Postal Code

2194

Country

Australia

Facility Name

Pfizer Investigational Site

City

Cairns

State/Province

Queensland

ZIP/Postal Code

4870

Country

Australia

Facility Name

Pfizer Investigational Site

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Pfizer Investigational Site

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Pfizer Investigational Site

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Pfizer Investigational Site

City

Shenton Park

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Pfizer Investigational Site

City

Santiago

State/Province

ZIP/Postal Code

7510186

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

State/Province

ZIP/Postal Code

8360156

Country

Chile

Facility Name

Pfizer Investigational Site

City

Providencia

State/Province

Santiago, RM

ZIP/Postal Code

7530206

Country

Chile

Facility Name

Pfizer Investigational Site

City

Vina del Mar

State/Province

V Region

ZIP/Postal Code

2570017

Country

Chile

Facility Name

Pfizer Investigational Site

City

Vina del Mar

ZIP/Postal Code

2570017

Country

Chile

Facility Name

Pfizer Investigational Site

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230001

Country

China

Facility Name

Pfizer Investigational Site

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230022

Country

China

Facility Name

Pfizer Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510260

Country

China

Facility Name

Pfizer Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

Facility Name

Pfizer Investigational Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

Pfizer Investigational Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Facility Name

Pfizer Investigational Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Pfizer Investigational Site

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Facility Name

Pfizer Investigational Site

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Facility Name

Pfizer Investigational Site

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266011

Country

China

Facility Name

Pfizer Investigational Site

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Facility Name

Pfizer Investigational Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Pfizer Investigational Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Pfizer Investigational Site

City

Beijing

ZIP/Postal Code

100020

Country

China

Facility Name

Pfizer Investigational Site

City

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Pfizer Investigational Site

City

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Pfizer Investigational Site

City

Shanghai

ZIP/Postal Code

200001

Country

China

Facility Name

Pfizer Investigational Site

City

Shanghai

ZIP/Postal Code

200003

Country

China

Facility Name

Pfizer Investigational Site

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Pfizer Investigational Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Pfizer Investigational Site

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

0000

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bucaramanga

State/Province

Santander

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Opatija

ZIP/Postal Code

51410

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Frederiksberg

ZIP/Postal Code

2000

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Helsinki

ZIP/Postal Code

00120

Country

Finland

Facility Name

Pfizer Investigational Site

City

Hyvinkaa

ZIP/Postal Code

05800

Country

Finland

Facility Name

Pfizer Investigational Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Pfizer Investigational Site

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Pfizer Investigational Site

City

Nuernberg

ZIP/Postal Code

90429

Country

Germany

Facility Name

Pfizer Investigational Site

City

Rheine

ZIP/Postal Code

48431

Country

Germany

Facility Name

Pfizer Investigational Site

City

Maroussi Athens

ZIP/Postal Code

15126

Country

Greece

Facility Name

Pfizer Investigational Site

City

Seremban

State/Province

Negeri Sembilan

ZIP/Postal Code

70300

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Batu Caves

State/Province

Selangor

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Subang Jaya

State/Province

Selangor

ZIP/Postal Code

47500

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Putrajaya

State/Province

Wilayah Persekutuan

ZIP/Postal Code

62250

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Torreon

State/Province

Coahuila

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58249

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62270

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

Queretaro

ZIP/Postal Code

76178

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Bialystok

ZIP/Postal Code

15-337

Country

Poland

Facility Name

Pfizer Investigational Site

City

Bialystok

ZIP/Postal Code

15-461

Country

Poland

Facility Name

Pfizer Investigational Site

City

Koscian

ZIP/Postal Code

64-000

Country

Poland

Facility Name

Pfizer Investigational Site

City

Poznan

ZIP/Postal Code

60-773

Country

Poland

Facility Name

Pfizer Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Nove Zamky

ZIP/Postal Code

94001

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Povazska Bystrica

ZIP/Postal Code

017 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Senica

ZIP/Postal Code

905 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Santiago de Compostela

State/Province

A Coruña

ZIP/Postal Code

15705

Country

Spain

Facility Name

Pfizer Investigational Site

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Pfizer Investigational Site

City

Malaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Pfizer Investigational Site

City

Falun

ZIP/Postal Code

791 82

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Goteborg

ZIP/Postal Code

413 46

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Rajathevee

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Amphoe Muang

State/Province

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Muang District

State/Province

Khonkaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Cannock

State/Province

Staffs

ZIP/Postal Code

WS11 2XY

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Solihull

State/Province

West Midlands

ZIP/Postal Code

B91 2JL

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Caracas

State/Province

DC/ Municipio Libertados

ZIP/Postal Code

1040-A

Country

Venezuela

Facility Name

Pfizer Investigational Site

City

Caracas

State/Province

Distrito Capital

ZIP/Postal Code

1010

Country

Venezuela

12. IPD Sharing Statement

Citations:

PubMed Identifier

35577477

Citation

Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.

Results Reference

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PubMed Identifier

35382883

Citation

Bartlett SJ, Bingham CO, van Vollenhoven R, Murray C, Gruben D, Gold DA, Cella D. The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials. Arthritis Res Ther. 2022 Apr 5;24(1):83. doi: 10.1186/s13075-022-02724-x.

Results Reference

derived

PubMed Identifier

34921355

Citation

Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

Results Reference

derived

PubMed Identifier

34870800

Citation

Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Results Reference

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PubMed Identifier

33127856

Citation

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

Results Reference

derived

PubMed Identifier

33059710

Citation

Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.

Results Reference

derived

PubMed Identifier

32816215

Citation

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

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PubMed Identifier

30425195

Citation

Li ZG, Liu Y, Xu HJ, Chen ZW, Bao CD, Gu JR, Zhao DB, An Y, Hwang LJ, Wang L, Kremer J, Wu QZ. Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis. Chin Med J (Engl). 2018 Nov 20;131(22):2683-2692. doi: 10.4103/0366-6999.245157.

Results Reference

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PubMed Identifier

30177460

Citation

Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.

Results Reference

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PubMed Identifier

29949132

Citation

Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.

Results Reference

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PubMed Identifier

28143815

Citation

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

Results Reference

derived

PubMed Identifier

27565000

Citation

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Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921046&StudyName=A%20Study%20Comparing%202%20Doses%20Of%20CP-690%2C550%20Vs.%20Placebo%20For%20The%20Treatment%20Of%20Rheumatoid%20Arthritis%20In%20Patients%20On%20Other%20Background%20Arthri

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A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

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A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Arthritis, Rheumatoid

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Arm 1

Arm 2

Arm 3

Arm 4

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Secondary Outcome Measures

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